Comparing a new procedure to medication for treating GERD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in patients with gastroesophageal reflux disease (GERD) who are currently treated with proton pump inhibitors (PPIs). Under general anesthesia, patients undergo an endoscopic procedure where a segment of mucosa at the esophagogastric junction is reconstructed to form a mucosal flap. The study aims to determine if this surgical approach can provide better outcomes compared to ongoing PPI therapy. Patients will be monitored for symptom relief and any complications following the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-60 years of age;
* Hiatal hernia ≤ 2 cm;
* Sliding hernia ≤ 2 cm;
* Recurrence of GERD symptoms after cessation of PPIs;
* On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks;
* Esophagitis (Los Angeles Classification) Grade B, C, or D;
* Hill's flap valve grade ≤ III;
* Observation of distal esophageal pH \< 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%;
* Normal or near-normal esophageal motility;
* Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg;
* DeMeester score ≥ 14.7 or total reflux episodes exceeding 73;
* Completion of a signed informed consent form.

Exclusion Criteria:

* BMI \> 35 kg/m2;
* ASA \> II;
* Barrett's esophagus;
* Hiatal hernia \> 2 cm;
* Esophagitis (Los Angeles Classification) Grade A or No esophagitis；
* Hill's flap valve grade \> III；
* Peptic ulcer disease;
* Primary esophageal motility disorders such as achalasia;
* Severe gastroparesis;
* History of previous esophageal or gastric surgery, including ARMS or ARMA;
* Uncontrolled systemic diseases;
* Gastric outlet obstruction;
* Pregnancy or planning to become pregnant.

Where it's running

• Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: jiaoyang j lu
• Email: lujiaoyang@sdu.edu.cn
• Phone: 18560089069

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predictors of symptom improvement after laparoscopic fundoplication

  This study tests what preoperative factors help predict which GERD patients will feel better after laparoscopic fundoplication.

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• Thread-Embedding Acupuncture plus a Proton Pump Inhibitor for GERD

  This study tests whether adding thread-embedding acupuncture to standard omeprazole treatment helps people with GERD who have a traditional Liver-Stomach constraint-heat pattern.

  Recruiting University of Science Ho Chi Minh City · Ho Chi Minh City · NCT07797959

• Managing GERD with personalized dietary changes and guided education

  A dietary plan and written education are being tested to see if they help adults with chronic GERD reduce symptoms.

  Recruiting Hualien Tzu Chi General Hospital · Hualien City, Taiwan · NCT07754721

• GERD patient registry study using a large prospective clinical database

  A large group of adults with gastroesophageal reflux disease are being looked at in real-world care to see who they are, what treatments they get, and how symptoms and well-being change after treatment.

  Recruiting Beijing Friendship Hospital · Beijing, Beijing Municipality · NCT07749989

• Mindfulness Intervention for Emotional Distress in GERD

  This online mindfulness program is being tested to see if it can help adults with GERD feel less emotional distress and experience fewer reflux symptoms.

  Recruiting at 13 sites Peking University · Beijing, Beijing Municipality and 14 other locations · NCT07667894

• Comparing two medications for treating gastroesophageal reflux disease symptoms

  This study is testing whether tegoprazan works better than pantoprazole in helping adults with gastroesophageal reflux disease (GERD) feel better after four weeks of treatment.

  Recruiting at 2 sites Phase 4 Carnot Laboratories · Mexico City, Mexico City and 1 other locations · NCT06991348

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.